Patients will have videocapsule colonoscopy after bowel preparation, followed by standard colonoscopy the next day.

Interventions:

Device: PillCam COLON 2 on D0

Procedure: Standard colonoscopy on D1

Device: PillCam Colon 2

PillCam® COLON 2 capsule endoscopy is a minimally invasive tool for direct visualization of the colon, including identifying the occurrence of polyps.

Procedure: Colonoscopy

Standard colonoscopy is the standard against which capsule endoscopy is compared.

Detailed Description:

Standard care after colorectal surgery is colon surveillance by standard colonoscopy with its benefits (gold standard examination, resection of lesions) and disadvantages (acceptability, general anesthesia, availability of qualified personnel, risk of perforation and associated gastrointestinal bleeding).

Use of a video-capsule (VCC) is a new, non-invasive technique, that allows to visualize the colon as a whole. This technique has the advantage of not requiring general anesthesia or air insufflation. The examination is performed as an outpatient procedure and therefore does not require hospitalization.

In previous studies, PillCam COLON 2 showed a good sensitivity and specificity in detecting colorectal lesions. However, its use requires an excellent bowel preparation.

To date, no study has been conducted using the VCC in monitoring patients with prior colorectal surgery, especially on the passage of the VCC through surgical anastomosis. No information on VCC capabilities to view and recognize surgical anastomoses and VCC transit time in surgically modified colon is available. The possibility to precisely locate a colorectal lesion prior to surgery, using the VCC, also remains to be studied.

The study requires a 2-month patient participation. The planned total study duration is 2 years.

Eligibility

Ages Eligible for Study:

18 Years to 85 Years

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

patient between 18 and 85 years old

patient with greater than 3 month follow-up for colorectal resection with ileo-colic , colo-colic or colorectal anastomosis, regardless of etiology

patient requiring a colonoscopy for regular medical care

absence of contra-indication to anesthesia and to colonoscopy conduct

patient able to understand the study related information and to provide written informed consent

patient wearing a pacemaker or any other internal electronic medical device

patient with deglutition disorders and/or altered state of consciousness

patient with serious disease preventing planned study procedures

pregnant or breast-feeding woman

patient within exclusion period from other clinical trial

patient having forfeited their freedom of an administrative or legal obligation

patient being under guardianship

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01879943